Celldex announces additional data on barzolvolimab

Celldex (CLDX) announced new data on exploratory endpoints further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria. Key data highlights from the ACAAI presentation: Barzolvolimab treatment demonstrated rapid and profound improvement in urticaria control with sustained efficacy, including after the completion of active therapy, in patients with CSU refractory to antihistamines. Significant improvements in urticaria control test over seven days scores were observed. UCT7 evaluates symptoms, quality of life, treatment adequacy and overall disease control within the past week. Patients on barzolvolimab experienced up to an 8.6 point improvement from baseline UCT7 scores compared to only 2.5 points for placebo at Week 12. This improvement deepened for patients on barzolvolimab to up 10.0 points at Week 52. Notably, meaningful clinical benefit continued beyond the active treatment period and at Week 76, seven months after the last dose of barzolvolimab, a 7.4 point improvement was observed. At Week 52, 71% of patients achieved complete disease control and 86% of patients achieved well-controlled disease at the 150 mg Q4W dose. Similar activity across both omalizumab naive and omalizumab refractory CSU was observed. Most patients had well controlled disease at Week 76 suggestive of disease modification. Barzolvolimab was well tolerated with no new safety findings during the follow up period.